Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Mirabegron Extended-Release Tablets, 25 mg and 50 mg, to market a generic equivalent of Myrbetriq Extended-Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development, Inc. The product will be manufactured at Lupin’s facility in Nagpur, India.
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, (RLD Myrbetriq) had estimated annual sales of $2403 million in the U.S. (IQVIA MAT June 2022).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
